Liver fibrosis is a pathological process through which chronic liver disease such as chronic hepatitis B, alcoholic liver disease, fatty liver etc. developed into liver cirrhosis. The formation and development of liver fibrosis crucially affect prognosis and outcome of chronic liver diseases, and treatment of liver fibrosis is the one of the two most challenging tasks in the clinical treatment of chronic liver diseases, the other being etiologic treatment. The statistics data shown that there are 1.5 billion hepatitis B infectors in our country, among which there are thirty million patients suffering from chronic hepatitis Bs. The hazard of chronic hepatitis is well documented, which could infect other people on one hand, on the other it could develop into liver fibrosis.
It is observed that 65 wt % of patients with slight hepatitis B have liver fibrosis, but 100 wt % in moderate and severe patients. Over 30 wt % of chronic hepatitis patients will inevitably develop into liver cirrhosis. Nowadays in China, more than 10 wt % of population suffers from fatty liver, in which 50 wt % patients are due to obesity and 57.5 wt % due to alcohol. In addition the incidence of alcoholic liver diseases will increase as the living standard improves. No matter alcoholic or non alcoholic fatty liver diseases, the incidence of liver fibrosis has reached 25 wt % of patient population, 1.5 wt %˜8 wt % of which will become liver cirrhosis.
Liver fibrosis is a active repairing reaction to chronic damage, which characters with extracellular matrix (ECM) overproduction and deposition and the morphological features of hepatic sinusoid capillarization and lobule fibrosis. Almost all the chronic liver diseases, including chronic hepatitis B and C, chronic schistosomiasis, chronic alcoholic and drug damage, autoimmunity liver diseases have the pathological feature of liver fibrosis. These diseases would develop into liver fibrosis as the fibrosis continues, accompanying by liver dysfunction and portal hypertension, which severely affect patients' health and threaten their life at last.
Modern medicine researches indicated that hepatic stellate cell activation is the cellular basis of liver fibrogenesis, while imbalance of ECM metabolism including collagens that character as its production exceeding degradation is the biochemical foundation of fibrosis. It is now recognized that liver fibrosis is reversible, and, to some degree, liver cirrhosis can also be reversed. Therefore anti-fibrosis treatment is not only important but feasible and of clinical significance.
An existent technology, which is a capsule preparation (China patent: 99113887.2), made from salvia miltiorrhiza, pruni persicae, cordyceps mycelial threads and so on, can be effective against liver fibrosis due to chronic hepatitis B. However, this preparation has some shortcomings, including the shortcomings in dosage, moisture absorption, stimulation to stomach and intestine and etc. And these drawbacks would affect the preparation's stability and pharmacodynamic function.